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YY/T 1410-2016Balance evaluation and exercise systems (English PDF)

平衡测试训练系统

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Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

March 23, 2016

Implementation date

January 1, 2017

Scope

YY/T 1410-2016 is the English-translated version of 平衡测试训练系统.

YY/T 1410-2016 is the Chinese pharmaceutical industry standard for the balance evaluation and exercise training system, the platform on which a patient's balance is measured and trained after disease or injury.

It gives the terms and definitions, the classification, the composition, the requirements and the test methods, covering the accuracy of the force and centre-of-pressure measurement, the sampling and the display, the moving platform where fitted and its limits, the safety of the patient, including the harness and the emergency stop, and the electrical safety. Issued on 23 March 2016, it has applied since 1 January 2017.

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Document preview — YY/T 1410-2016

National Standard of the People's Republic of China

ICS: 11.040.60
Classification: C 42

Issued by: National Medical Products Administration of the People's Republic of China

Preface
1 Scope
2 normative reference document
3 Terms and definitions
5 composition
6 requirements
7 Test method

Foreword

This standard is drafted in accordance with the rules given in GB/T 1.1-2009.

1 Scope

This standard specifies the terms and definitions, classification, composition, requirements and test methods of the balance test training system.

This standard applies to the balanced test training system (hereinafter referred to as "balancing system") specified in 3.1. The balancing system is expected to be used for disease or Injury - induced rehabilitation of patients with balanced dysfunction under condition of medical care.

2 Normative reference documents

The following documents are indispensable for the application of this document. For dated references, only the dated edition applies to this document. For undated references, the latest edition (including all modifications) applies to this document.

GB 9706.1-2007 Medical electrical equipment - Part 1. General requirements for safety (IEC 60601-1. 1988, IDT) A support device for mounting the load plate.

GB 9706.15-2008 Medical electrical equipment - Part 1-1. General requirements for safety - Side standard. Medical electrical system safety (IEC 60601-1-1.:2000, IDT) Environmental requirements and test methods for medical appliances GB/T 14710-2009

GB/T 16886.1 Biological evaluation of medical devices - Part 1. Evaluation and testing in risk management (GB/T 16886.1-2011, ISO 10993-1.:2009, IDT)

YY 0505-2012 Medical electrical equipment - Part 1-2. General requirements for safety - Parallel standards. Electromagnetic compatibility requirements and tests (IEC 60601-1-2.:2004, IDT)

3 Terms and definitions

GB 9706.1-2007 and the following terms and definitions apply to this document.

3.1 Balance test training system

The use of the patient's center of gravity track measurement and evaluation results, to guide the image so that the patient consciously control the focus to achieve balanced function training Purpose of medical rehabilitation equipment.

3.2 Support bench (chairs)

A support device for mounting the load plate.

3.3 Force plate

Placed on a support (chair), in contact with the patient and used to collect the pressure signal.

4 Classification

Balanced system in accordance with the training can be divided into standing, sitting.

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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 20 pages — is available in the English PDF.

Referenced standards

Normative references

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